FDAFDA · Food and drugs·Recall number D-0561-2016
Azithromycin 500 mg tablets, Rx Only, packaged in a) 1 count, b) 2 count, c) 3 count, and d) 7 count bottles, Packaged by: PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, Mfr: Wokhardt Ltd., Mumbai, India, NDC: a) 55289-274-79, b) 55289-274-02, c) 55289-274-03, d) 55289-274-07.
Published January 13, 2016 · Recall initiated: April 29, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- PD-Rx Pharmaceuticals, Inc.
- Distributor
- Nationwide
- Lot
- Lot #s: J12C03, J12D19, Exp 10/14, L12B52, L12E79, L12G92, Exp 12/14, A13G14, A13H49, Exp 01/15, B13G53, Exp 02/15, D13A66, Exp 04/15, E13E35, Exp 05/15, F13A58, F13D85, F13F17, F13F27, Exp 06/15, G13D37, G13E57, Exp 07/15, H13A65, H13A74, H13C13, H13G01, Exp 08/15, I13C02, I13G98, Exp 09/15, J13C53, J13G90, Exp 10/15, K13A65, K13B73, K13C98, K13E61, Exp 11/15, L13C59, L13F49, A14C27, A14D09, A14F11, Exp 12/15.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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